A Phase 2 interventional study of placebo and Anfibatide in ST Segment Elevation Myocardial Infarction, sponsored by Lee's Pharmaceutical Limited. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-07-13.
Sponsored by Lee's Pharmaceutical Limited · Phase 2, Interventional, and Treatment
A Phase IIb clinical trial to investigate the safety and efficacy of antiplatelet thrombolysin injection for patients with ST Segment Elevation Myocardial Infarction (STEMI) before receiving PCI therapy, in order to provide evidence for Phase III design.
Anfibatide is a snake venom, and we have investigated it in humans for many years with phase 1\&2a studies. A Phase IIb clinical trial to investigate the safety and efficacy of antiplatelet thrombolysin injection for patients with ST Segment Elevation Myocardial Infarction (STEMI) before receiving PCI therapy, in order to provide evidence for Phase III design.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's planned enrollment of 240 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Lee's Pharmaceutical Limited is the lead sponsor of 73 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients received GPIIb/IIIa receptor antagonists and/or thrombolytic therapy before randomization;
Patients who have hemorrhage risk:
Patients with coagulation disorder:
5IU/60 kg bolus and 0.002 IU/kg/h continuous infusion for 48 hours
Drug: placebo
5IU/60 kg bolus and 0.002 IU/kg/h continuous infusion for 48 hours
Drug: Anfibatide
Freeze-dried powder without snake venom will be dissovled in saline
Freeze-dried powder with snake venom will be dissovled in saline
ratio of TMPG grade 2 and grade 3
After PCI, TMPG grade will be evaluated and
Time frame: within 24 hours
inhibition rate of platelet aggregation and GP1b receptor combination rate
Baseline, 15-20 minutes after injection, 24-26 hours after injection, 48-50 hours after injection, 8-10 hours after the cease of medication, the comment and analysis of the inhibition rate of platelet aggregation and GP1b receptor combination rate
Time frame: 48 hours
Patients ratio of no-reflow to slow-flow in coronary artery after PCI therapy
Time frame: 24 hours
Analysis of iconography reference: instant TIMI, CTFC and TMPG before/after the target vessel revascularization PCI therapy
Time frame: 24 hours
The depression level of ST segment from right after the PCI therapy to 2 hours later
i. Complete: depression level ≥ 70% ii. Partially: 30% ≤ depression level \< 70% iii. None: \< 30%
Time frame: within 24 hours
Compare the baseline troponin level to the troponin level at 24-26 hours after injection and at 3 days after the surgery respectively
Time frame: 72 hours
(6) Check the CMR at 3-5 days after the surgery, evaluate the Myocardium Salvage Index (MSI)
Time frame: 5 days
(7) While surgery and hospitalization, follow the ratio and dose as suggested by the surgeon in case of emergency use of GP IIb/IIIa receptor antagonist or other antiplatelet drug
Time frame: 5 days
(8) Clinical endpoint 30 days after surgery (caused by death, non-fatal myocardial infarction reissue, blood clot formation after stent implantation, non-fatal stroke, target lesion revascularization reissue) and the analysis of the causes
Time frame: 30days
Recorded hemorrhage issues for 30 days after the surgery (BARC hemorrhage standard)
Time frame: 30days
This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Lee's Pharmaceutical Limited